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510(k) Data Aggregation

    K Number
    K132704
    Device Name
    DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
    Manufacturer
    BIOMET
    Date Cleared
    2013-10-09

    (41 days)

    Product Code
    LXT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K112345
    Why did this record match?
    Device Name :

    DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

    Device Description

    The Distal Radius Volar Rim Plating System consists of a series of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr used in bone fixation and the management of fractures and reconstructive surgeries in narrow to standard head widths.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Distal Radius Volar Rim Plating System). It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies using a test set of data (clinical or otherwise) to demonstrate a specific level of performance.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

    Specifically, the document lacks the following information required to answer your questions:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for a test set or data provenance.
    • Number of experts or their qualifications for ground truth establishment.
    • Adjudication method for a test set.
    • Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Results from a standalone algorithm performance study.
    • Type of ground truth used (clinical outcomes, pathology, expert consensus, etc.).
    • Sample size for a training set.
    • How ground truth for a training set was established.

    The "Summary of Substantial Equivalence" section only mentions "pre-clinical data including axial load construct testing, evaluation of galvanic corrosion potential, tab bending and function" to demonstrate similarity to predicate devices, but these are general engineering tests, not studies assessing diagnostic or clinical performance against acceptance criteria using patient data or expert consensus.

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